Mer­ck, Pfiz­er line up a big FDA de­ci­sion on a block­buster hope­ful, star­ing down some ma­jor league com­pe­ti­tion

Two Big Phar­ma col­lab­o­ra­tors — Mer­ck and Pfiz­er — have moved their SGLT2 di­a­betes drug hope­ful er­tugliflozin in­to the hands of reg­u­la­tors on both sides of the At­lantic.

Armed with pos­i­tive piv­otal da­ta, Mer­ck and Pfiz­er are up for three PDU­FA dates in De­cem­ber now: Monother­a­py, a com­bo with best­selling di­a­betes drug Janu­via and an­oth­er com­bi­na­tion with long­time di­a­betes stan­dard met­formin. The same trio of ap­pli­ca­tions is al­so now un­der re­view in Eu­rope.

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